Etravirine

Etravirine is an antiviral medicine that is used along with other medicines to treat human immunodeficiency virus (HIV). HIV leads to acquired immunodeficiency syndrome (AIDS). Etravirine is not a cure for HIV or AIDS.

Etravirine is for adults and children who are at least 2 years old.

Etravirine may also be used for reasons not mentioned in this medication guide.

Etravirine must be taken with other antiviral medications and should not be used by itself.

Follow all instructions on your prescription label and read all medication guides or information sheets. Use the medicine exactly as directed.

Etravirine works best if taken after a meal. Do not take it on an empty stomach.

Etravirine doses for children are based on their weight. Your child's dose may need to change if they gain or lose weight.

Do not crush, chew, or break an etravirine tablet. Swallow it whole with a drink such as water.

If you cannot swallow a tablet whole, put it in a glass with a teaspoon of water. Stir until the water looks milky. Add a tablespoon more water (or a tablespoon of orange juice, milk, or sports drink). Drink this mixture right away. Add more liquid to the glass, swirl gently, and drink right away. Keep adding and drinking liquid until the entire dose is rinsed from the glass.

You will need regular medical tests.

Store the tablets in their original container at room temperature, away from moisture and heat.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should continue to see a doctor.

Etravirine must be taken along with other HIV medications. However, some drugs can increase or decrease the amount of etravirine in your blood. Etravirine can also change the blood levels of some other drugs. This may make your medications less effective or cause more side effects. TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE.

You should not take etravirine if you are allergic to it.

Tell your doctor if you have ever had liver disease, including hepatitis B or C.

Etravirine must be taken with other HIV medications. However, there are some combinations of medicines that should not be used with etravirine. Tell your doctor about all your current medicines and any medicine you start or stop using.

Tell your doctor if you are pregnant. Your dose may need to be different during pregnancy. Use your medications correctly to manage your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy.

Your name may be on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Etravirine may cause serious side effects. Call your doctor at once if you have:

• unexplained muscle pain, tenderness, or weakness;
• fever, unusual tiredness;
• dark colored urine; or
• any type of skin rash, no matter how mild.

Etravirine affects your immune system, which may cause certain side effects (even weeks or months after you've taken etravirine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of etravirine may include:

• diarrhea;
• numbness or tingling in your hands or feet;
• rash; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for HIV Infection:

200 mg orally twice a day after a mealComments:-The same dosage is recommended for adult and pregnant patients.Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in antiretroviral therapy-experienced patients

Usual Pediatric Dose for HIV Infection:

2 to less than 18 years:-Weight 10 to less than 20 kg: 100 mg orally twice a day after a meal-Weight 20 to less than 25 kg: 125 mg orally twice a day after a meal-Weight 25 to less than 30 kg: 150 mg orally twice a day after a meal-Weight at least 30 kg: 200 mg orally twice a day after a mealUse: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in antiretroviral therapy-experienced patients

Take the medicine after your next meal, but if you are more than 6 hours late for the dose, skip the missed dose. Do not take two doses at the same time.

Get your prescription refilled before you completely run out of medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using etravirine will not stop your disease from spreading. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Sometimes, it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect etravirine, especially:

• other drugs to treat HIV;
• an antibiotic or antifungal medicine;
• a blood thinner;
• heart rhythm medicine;
• medicine for erectile dysfunction or pulmonary arterial hypertension;
• medicine to prevent organ transplant rejection;
• medicine to treat hepatitis C;
• medicine to treat opioid addiction;
• medicine to treat or prevent malaria;
• seizure medication;
• "statin" cholesterol medication; or
• St. John's wort.

This list is not complete, and many other drugs may affect etravirine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.